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A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539601
Recruitment Status : Terminated (This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.)
First Posted : May 29, 2018
Results First Posted : January 10, 2022
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD.

A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to <18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Crisaborole ointment, 2% Drug: Hydrocortisone butyrate cream, 0.1% Drug: Pimecrolimus cream, 1% Drug: Crisaborole Vehicle Phase 4

Detailed Description:

Approximately 600 subjects will be enrolled in the study, of which at least 150 subjects aged 2-6; at least 140 subjects aged 7-11; at least 120 subjects aged 12-17 and up to 90 subjects will be adults. Subjects must have mild-moderate AD involving at least 5% treatable %BSA assessed on baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD involved, excluding the scalp.

Eligible subjects will be randomized at the Baseline/Day 1 visit. Randomization will be stratified by eligibility for TCS or TCI treatment as per national approved labels. Cohort 1 will be for subjects who are eligible for TCS therapy, and Cohort 2 will be for subjects who are not eligible for TCS therapy but eligible for TCI therapy. The investigational products will be applied BID for 28 days to the Treatable body surface area (BSA) identified at Baseline/Day 1.

The primary efficacy endpoint is the percent change from baseline in the Eczema Area and Severity Index (EASI) total score at Day 29.

For the efficacy comparison of crisaborole versus vehicle, subjects from both Cohort 1 and Cohort 2 are included in the analysis, adjusted for cohort effect. For the efficacy comparison of crisaborole versus TCS, only subjects from Cohort 1 are included in the analysis. For the comparison of crisaborole versus TCI, only subjects from Cohort 2 are included in the analysis.

Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.

Scheduled study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (End of treatment/Early termination), Day 43 or 14 Days after last dose if subject is terminated early from treatment. A follow up telephone call will be made by site staff to the subjects/subject's legally acceptable guardian(s) on Day 60 or at least 28 days after last dose if subject is terminated early from treatment. The Day 60 visit will be completed in the clinic for subjects enrolled in the OCT sub-study.

To further explore the benefit/risk of crisaborole ointment, 2%, a sub-study to evaluate differences in atrophic skin changes across study treatment groups in Cohort 1 will be conducted at select sites.

The sub-study will include obtaining Optical coherence tomography (OCT) imaging to evaluate atrophic changes in epidermal thickness during and after treatment with study investigational product in Cohort 1. This sub-study also provides an opportunity to explore differences in Transepidermal Water Loss (TEWL) and cutaneous inflammatory and barrier biomarkers associated with AD within the stratum corneum (SC) across treatment groups in Cohort 1. The Aquaflux (an evaporimeter) will be used in this sub-study to evaluate TEWL during and after treatment at select sub-study centers. Tape-strips will also be used in this sub-study to evaluate SC biomarkers from AD lesional and non-lesional skin.

This sub-study will include approximately 60 subjects from Cohort 1 that are enrolled in the main study (C3291037). Subjects will follow the main study assessments and visits as per the schedule of activities for the main study but will also follow additional procedures as described in the protocol. The telephone call at Day 60 in the main study is replaced with an in-clinic visit for sub-study participants.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The investigational products above are masked for appearance, and will be placed into identical cartons. Once removed from the product cartons, the investigational products could be discerned from each other based on commercial product tube shape/size and should only be handled by unblinded site personnel.

Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.

Primary Purpose: Treatment
Official Title: A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED, VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY, SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
Actual Study Start Date : April 27, 2018
Actual Primary Completion Date : December 11, 2020
Actual Study Completion Date : December 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Crisaborole ointment, 2%
This treatment arm will be administered both in Cohort 1 and Cohort 2.
Drug: Crisaborole ointment, 2%
Applied twice a day (BID)
Other Name: Eucrisa

Active Comparator: Hydrocortisone butyrate cream, 0.1%
This treatment arm will be administered in Cohort 1 only.
Drug: Hydrocortisone butyrate cream, 0.1%
Applied BID
Other Name: Locoid 0.1%

Active Comparator: Pimecrolimus cream, 1%
This treatment arm will be administered in Cohort 2 only.
Drug: Pimecrolimus cream, 1%
Applied BID
Other Name: Elidel

Placebo Comparator: Crisaborole Vehicle
This treatment arm will be administered both in Cohort 1 and Cohort 2.
Drug: Crisaborole Vehicle
Applied BID




Primary Outcome Measures :
  1. Percent Change From Baseline in the Eczema Area and Severity Index (EASI) Total Score at Day 29 [ Time Frame: Baseline, Day 29 ]
    EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and percent (%) body surface area (%BSA) affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck [h], upper limbs [u], trunk [t] [including axillae, groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) based upon %BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%), 6 (90 to 100%). Total EASI score (aged >=8 years) =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et + It +Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll); for aged 2 to <8 years =0.2*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.3*Al*(El + Il + Exl + Ll). Total score ranges from 0.0 to 72.0, higher scores indicated greater AD severity.

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Discontinuations Due to AEs and SAEs [ Time Frame: From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days) ]
    An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs are events between the first dose of study drug up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A SAE is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event.

  3. Number of Participants With Local Tolerability Adverse Events (AEs) [ Time Frame: From Baseline up to 28 days after last dose of study treatment (maximum up to 60 Days) ]
    Local tolerability AEs included application and instillation site reactions, application site discharge, application site erythema, application site exfoliation, application site pain, application site pruritus, application site swelling, dermatitis and eczema, dermatitis atopic, dermatitis contact, eczema, skin irritation, telangiectasia and related conditions, and urticarias.

  4. Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: Screening up to Day 29 ]
    Vital sign measurements included temperature, respiratory rate, pulse rate, and blood pressure. Temperature, respiratory rate, pulse rate, and blood pressure were taken in the seated or supine position, after the participant has been sitting or lying calmly for a minimum of 5 minutes (when possible for younger children). Position of recording was consistent within participant through-out the study.

  5. Number of Participants With Clinically Significant Abnormal Laboratory Parameters [ Time Frame: Screening up to Day 29 ]
    Hematology parameters included with criteria greater than (>) 1.2*upper limit of normal (ULN): leukocytes (10^3 per cubic millimeter [10^3/mm^3]), lymphocytes (10^3/mm^3), lymphocytes/leukocytes (%), neutrophils (10^3/mm^3), neutrophils/leukocytes (%), basophils/leukocytes (%), eosinophils (10^3/mm^3), eosinophils/leukocytes (%), monocytes (10^3/mm^3), monocytes/leukocytes (%). Clinical chemistry included parameters: aspartate aminotransferase (units per liter [U/L]) (>3.0* ULN), alanine aminotransferase (U/L) (>3.0* ULN), alkaline phosphatase (U/L) (>3.0* ULN), creatinine (milligram per deciliter [mg/dL]) (>1.3* ULN), potassium (milliequivalent per liter [mEq/L]) (>1.1* ULN), bicarbonate (mEq/L) (>1.1* ULN).


Secondary Outcome Measures :
  1. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 8, 15 and 22 [ Time Frame: Baseline, Day 8, 15 and 22 ]
    EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and %BSA affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck [h], upper limbs [u], trunk [t] [including axillae, groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score(A) based upon %BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%), 6 (90 to 100%). Total EASI score (aged >=8 years) =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et + It +Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll); for aged 2 to <8 years =0.2*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.3*Al*(El + Il + Exl + Ll). Total score ranges from 0.0 to 72.0, higher scores indicated greater AD severity.

  2. Number of Participants Who Achieved Success in the Investigator's Static Global Assessment (ISGA) (ISGA Score of Clear [0] or Almost Clear [1] With At-least a 2-Grade Improvement From Baseline) at Day 8, 15, 22 and 29 [ Time Frame: Day 8, 15, 22 and 29 ]
    ISGA is a five point global assessment scale of AD severity, used to characterize participants' overall disease severity across all treatable AD lesions (excluding the scalp). ISGA score ranged from 0 to 4: where 0= clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity of AD.

  3. Number of Participants Who Achieved Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 8, 15, 22 and 29 [ Time Frame: Day 8, 15, 22 and 29 ]
    ISGA is a five point global assessment scale of AD severity, used to characterize participants' overall disease severity across all treatable AD lesions (excluding the scalp). ISGA score ranged from 0 to 4: where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity of AD.

  4. Number of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 8, 15, 22 and 29 [ Time Frame: Day 8, 15, 22 and 29 ]
    EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and %BSA affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck [h], upper limbs [u], trunk [t] [including axillae, groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score(A) based upon %BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%), 6 (90 to 100%). Total EASI score (aged >=8 years) =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et + It +Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll); for aged 2 to <8 years =0.2*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.3*Al*(El + Il + Exl + Ll). Total score ranges from 0.0 to 72.0, higher scores indicated greater AD severity.

  5. Time to First Improvement From Baseline in Eczema Area and Severity Index (EASI) Total Score of Greater Than or Equal to (>=) 75% [ Time Frame: Baseline up to Day 43 ]
    EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and %BSA affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck [h], upper limbs [u], trunk [t] [including axillae, groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score(A) based upon %BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%), 6 (90 to 100%). Total EASI score (aged >=8 years) =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et + It +Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll); for aged 2 to <8 years =0.2*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + Exu + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.3*Al*(El + Il + Exl + Ll). Total score ranges from 0.0 to 72.0, higher scores indicated greater AD severity.

  6. Change From Baseline in Percent Body Surface Area (%BSA) at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22 and 29 ]
    Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae) and lower limbs (including buttocks) excluding scalp. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand in a closed position) fitting in affected area of a body region was estimated. Maximum number of handprints were: 10 for head, neck (20 for <8 years age), 20 for upper limbs, 30 for trunk, 40 for lower limbs (30 for <8 years age). Surface area (SA) of body region equivalent to 1 handprint: 10% for head, neck (5% for <8 years age), 5% for upper limbs, 3.33% for trunk, 2.5% for lower limbs (3.33% for <8 years age). Overall %BSA for a body region = total number of handprints in a body region * % SA equivalent to 1 handprint. % BSA for an individual: mean of % BSA of all 4 body regions, range =0-100%, higher values = greater AD severity.

  7. Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Participants Aged Greater Than or Equal to (>=) 12 Years at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22 and 29 ]
    The severity of itch (pruritus) due to AD was assessed using the peak pruritus NRS for participants aged >=12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  8. Change From Baseline in Participant Reported Itch Severity Scale in Participants Aged 6-11 Years at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22 and 29 ]
    The severity of itch (pruritus) due to AD was assessed using the five-category participant reported itch severity scale for participants aged 6-11 years. Participants at specified time points were asked to "circle the face that shows how itchy your skin has been today". The scale ranged from 0 to 4, where 0= no itch and 4= very itch. Higher scores indicated worse itch.

  9. Change From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22 and 29 ]
    The severity of itch (pruritus) due to AD was assessed using the participant reported itch severity scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  10. Time to Greater Than or Equal to (>=2) Point Improvement From Baseline in Peak Pruritus Numeric Rating Scale (NRS) in Participants Aged Greater Than (>) 12 Years [ Time Frame: Baseline up to Day 29 ]
    The severity of itch (pruritus) due to AD was assessed using the peak pruritus NRS for participants aged >12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  11. Time to >= 3 Point Improvement From Baseline in Peak Pruritus Numeric Rating Scale (NRS) in Participants Aged Greater Than (>)12 Years [ Time Frame: Baseline up to Day 29 ]
    The severity of itch (pruritus) due to AD was assessed using the Peak Pruritus NRS for participants aged >12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  12. Time >=2 Point to Improvement From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years [ Time Frame: Baseline up to Day 29 ]
    The severity of itch (pruritus) due to AD was assessed using the patient reported itch severity scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  13. Time to >=3 Point Improvement From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years [ Time Frame: Baseline up to Day 29 ]
    The severity of itch (pruritus) due to AD was assessed using the Patient Reported Itch Severity Scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  14. Number of Participants Who Achieved >=2 Point Improvement From Baseline in Peak Pruritus Numeric Rating Scale (NRS) in Participants Aged Greater Than or Equal to (>=) 12 Years at Day 8, 15, 22 and 29 [ Time Frame: Day 8, 15, 22 and 29 ]
    The severity of itch (pruritus) due to AD was assessed using the peak pruritus NRS for participants aged >=12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  15. Number of Participants Who Achieved >=3 Point Improvement From Baseline in Peak Pruritus Numeric Rating Scale (NRS) in Participants Aged Greater Than or Equal to (>=) 12 Years at Day 8, 15, 22 and 29 [ Time Frame: Day 8, 15, 22 and 29 ]
    The severity of itch (pruritus) due to AD was assessed using the Peak Pruritus NRS for participants aged >=12 years. Participants at specified time points were asked the following question: "how would you rate your itch at the worst moment during the previous 24 hours?" The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  16. Number of Participants Who Achieved Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years at Day 8, 15, 22 and 29 [ Time Frame: Day 8, 15, 22 and 29 ]
    The severity of itch (pruritus) due to AD was assessed using the Patient Reported Itch Severity Scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  17. Number of Participants Who Achieved Greater Than or Equal to (>=) 3 Point Improvement From Baseline in Observer Reported Itch Severity Scale in Participants Aged Less Than (<) 6 Years at Day 8, 15, 22 and 29 [ Time Frame: Day 8, 15, 22 and 29 ]
    The severity of itch (pruritus) due to AD was assessed using the Patient Reported Itch Severity Scale for participants aged <6 years. Participant's caregivers at specified time points were asked the following question "how would you rate your observation of your child's itch (scratching, rubbing) at the worst moment during the previous 24 hours?". The scale ranged from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

  18. Change From Baseline in Dermatology Life Quality Index (DLQI) in Participants Greater Than or Equal to (>=) 16 Years at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22 and 29 ]
    DLQI is a 10-item questionnaire that measures the impact of skin disease on participants aged >=16 years. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participant.

  19. Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants Aged 4-15 Years at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22 and 29 ]
    The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children's (aged 4 to 15 years) quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The CDLQI total score was the sum of individual scores of question 1-10 and ranged from 0 (not at all) to 30 (very much): 0-1 = no effect on the child's life; 2-6 = small effect; 7-12 = moderate effect; 13-18 = very large effect; 19-30 = extremely large effect. Higher scores indicated more impact on quality of life of children.

  20. Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) in Participants Aged 2-17 Years at Day 8, 15, 22 and 29 [ Time Frame: Baseline, Day 8, 15, 22 and 29 ]
    The DFI was a 10-item disease questionnaire that measures the impact of having a child (aged 2-17 years) with AD on family quality of life. It was completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question was scored on a 4-point scale ranging from 0 (not at all) to 30 (very much): where higher scores indicated worst quality of life of family. The DFI total score was the sum of individual scores of the 10 questions and ranged from 0 (no impact on life of family) to 30 (maximum effect on life of family), where higher DFI scores indicated maximum effect on life of family.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.

Exclusion Criteria:

Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome.

Subjects in Cohort 1 are excluded if they have a contraindication for treatment with hydrocortisone butyrate cream 0.1%

Subjects in Cohort 2 are excluded if they have a contraindication for treatment with pimecrolimus cream, 1%


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539601


Locations
Show Show 32 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] August 12, 2019
Statistical Analysis Plan  [PDF] November 10, 2020

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03539601    
Other Study ID Numbers: C3291037
2018-001043-31 ( EudraCT Number )
First Posted: May 29, 2018    Key Record Dates
Results First Posted: January 10, 2022
Last Update Posted: January 10, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Atopic Dermatitis, Crisaborole ointment 2%, TCS, TCI
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrocortisone
Pimecrolimus
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action